All Features
Natalie Weber
Unlike Covid-19, remote audits aren’t unprecedented. Remote audits didn’t start with the pandemic, although it has forced more companies to use them than previously. At MasterControl, we’ve been doing remote audits for years for our international customers. It saves time and expense, and it’s every…
Steven Stein
Recently there have been a number of articles whose authors discuss conducting assessments remotely because of the pandemic. This article will discuss my experience with an actual assessment conducted remotely, how the plan changed in response to the pandemic, lessons learned, and some of my…
Sanjay Mishra
As the weather cools, the number of infections of the Covid-19 pandemic are rising sharply. Hamstrung by pandemic fatigue, economic constraints, and political discord, public health officials have struggled to control the surging pandemic. But now, a rush of interim analyses from pharmaceutical…
Nader Moayeri
I am part of a grassroots effort at the National Institute of Standards and Technology (NIST) that is developing an exposure notification system for pandemics in general, though we hope it could be used in at least a limited fashion during the current Covid-19 pandemic. We are fortunate at NIST to…
Alper Kerman
Huh? What? At least that was my response the first time I heard the words "zero trust" when I started working at the National Institute of Standards and Technology (NIST) National Cybersecurity Center of Excellence (NCCoE) in the fall of 2018. Mind you, I was also making a fresh start with an…
Gleb Tsipursky
Does the phrase “garbage in—garbage out” (GIGO) ring a bell? That’s the idea that if you use flawed, low-quality information to inform your decisions and actions, you’ll end up with a rubbish outcome. Yet despite the popularity of the phrase, we see such bad outcomes informed by poor data all the…
Hamza Mudassir
Disney has announced a significant restructuring of its media and entertainment business, boldly placing most of its growth ambitions and investments into its recently launched streaming service, Disney+. The 97-year-old media conglomerate is now more like Netflix than ever before.
What this means…
Victor Piedrafita
During the last decade, we’ve witnessed the emergence of sustainability issues among the most important business concerns in a firm’s supply chain. An increasing number of firms have reexamined their relations with suppliers and moved forward to build a more sustainable supply network, by not only…
Erik Fogelman, Jeff Orszak
With the increasing power of digital technology, the idea of a connected manufacturing system that can sense, analyze, and respond will soon be a reality. This idea—called “intelligent edge”—combines computing power, data analytics, and advanced connectivity to allow responses to be made much…
John Keogh
Almost all businesses involved in the food supply chain have experienced effects ranging from a mild shock to severe disruptions during the Covid-19 pandemic, and further disruptions may be ahead this winter.
Yet not all organizations have learned critical lessons, and history shows us some…
Grant Ramaley
IEC 60601-1: “Medical electrical equipment,” edition 3.1, is the base medical-device standard to ensure “basic safety and essential performance” of medical electrical equipment. It is used by medical device regulators but also recognized by some other regulatory authorities as a regulatory…
Zane Patalive
Meet Humphrey. Humphrey is a gray squirrel that a friend of mine rescued as an abandoned baby squirrel. For weeks, my friend and his family nursed the young creature by hand. While Humphrey was growing, he became very friendly with the family members, often perching on their shoulders and snuggling…
Celia Paulsen
October happens to be (among other things) Breast Cancer Awareness Month, Dental Hygiene Month, National Bullying Prevention Month, and my personal favorite, National Pizza Month. Plus, it’s Halloween! But I digress. We’re here to talk about cybersecurity.
Every manufacturer should hold…
Gleb Tsipursky
‘It’s not going away, and we have to face that reality.” That’s what the CEO and founder of a quality-centered high-tech manufacturing startup with 180 employees told the leadership team in early July 2020 to convince them of the need to do a strategic pivot to address Covid-19.
Previously, the…
Eric Stoop
Data can transform manufacturing. It’s also a term that continues to prompt discussions within the industry. People have been saying it for years now, and there is plenty of empirical evidence: Data are the way forward in business generally and manufacturing in particular.
But right now, when…
Mark Williams
One of the favorite aspects of my career in the insurance industry is delivering a positive outcome to someone in the midst of a personally challenging situation. Whether it’s giving someone the means to provide for care when health starts to fail, or a cushion to ease financial burdens after the…
NordVPN Teams
The FBI reported earlier this year that complaints of cyber attacks received by its cyber division had risen to almost 4,000 a day—a 400-percent increase over pre-coronavirus numbers. In one four-month period (January to April), 907,000 spam messages, 737 incidents related to malware, and 48,000…
Merilee Kern
As Covid-19 rages on, warning sirens have sounded of late amid a flurry of headlines surrounding ultraviolet C (UVC) light device-safety issues. Rightfully so, as the current pandemic has ushered in a veritable wild west of UVC gadget deployments with subpar consumer safeguards, instructions, or…
Tinglong Dai, Guihua Wang, Ronghuo Zheng
The Covid-19 pandemic has crippled the airline industry. Passenger numbers are down more than two-thirds from last year, and airlines have been canceling flights and shutting down routes.
It’s frustrating for travelers, but for patients on organ transplant waiting lists, the loss of flights can…
Ayman Jawhar
As a business leader, you probably think similarly to McKinsey about what makes a great product manager (PM): a perfect combination of skills like business acumen, market orientation, and technical skill as well as soft ones... the usual suspects.
Unfortunately (or fortunately, depending on your…
Gleb Tsipursky
Although deeply fulfilling, establishing and growing a quality-oriented startup poses serious dangers for the mental health of quality leaders. During the expansion stage, a founder will often face brutally long work weeks, pressure from different sources to manage the startup while raising funding…
Ryan E. Day, Dirk Dusharme @ Quality Digest, Taran March @ Quality Digest
In order to best illustrate how enterprisewide SPC software can help address shop-floor problems and then funnel the captured data to the corporate level where strategic issues can be analyzed, here is a case study of a hypothetical manufacturing facility. In it, the company makes effective use of…
Jon Speer
Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk.
Although risk is a variable we encounter in everyday life, it means something uniquely different to the medical device industry.…
Tom Taormina
After more than 50 years as a quality control engineer and having worked with more than 700 companies, it is my observation that the vast majority of quality professionals hold their prime directive to be reducing defects to the lowest acceptable level by minimizing process variability. Most of us…
Amitrajeet Batabyal
Arguing against globalization is like arguing against the laws of gravity, said former United Nations Secretary General Kofi Annan. Globalization, the international trade in goods and services with minimal barriers between countries, may seem inevitable as the world’s economies become more…
